scholarly journals Factors contributing to fidelity in a pilot trial of individualized resistant starches for pediatric inflammatory bowel disease: a fidelity study protocol

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Gisell Castillo ◽  
David R. Mack ◽  
Manoj M. Lalu ◽  
Ruth Singleton ◽  
Dean A. Fergusson ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Data Collection ◽  
Bowel Disease ◽  
Pilot Trial ◽  
Study Results ◽  
Inflammatory Bowel ◽  
Stool Samples ◽  
Resistant Starches ◽  
Trial Intervention ◽  
Trial Participants

Abstract Background The consumption of resistant starches is a promising adjuvant therapy for patients with inflammatory bowel disease. Rigorous evaluation of resistant starches in this setting depends on the intervention being delivered, received, and enacted as intended, that is, with fidelity. As part of a planned pilot trial, participants will be randomized to ingest resistant starches or a placebo. They will also be asked to collect stool samples and keep symptom and dose diaries to inform trial outcomes. We aim to identify potential factors impacting fidelity to the receipt and enactment of trial intervention and data collection activities from the perspective of patients and caregivers in the trial. Identifying fidelity barriers and enablers at the pilot trial phase of a clinical intervention may help to determine optimization processes when expanding to multiple sites in future trials. Methods We will conduct 15-30 semi-structured interviews with pilot trial participants (aged 8-17) and their caregivers. Trial participants will be approached for interviews approximately 6 months after the start of their trial participation. Personal projects analysis, a tool for understanding how individuals manage competing demands in their daily lives, will guide an in-depth exploration of how trial participants engage in activities related to intervention and data collection fidelity (ingesting resistant starches or placebo, collecting stool samples, keeping a symptom and dose diary) amidst the complexities of daily living. Discussion The present study will seek to explore and demonstrate how theory-informed fidelity assessments can be conducted alongside pilot trials to inform future multisite trials. Study results will clarify what factors may affect fidelity to trial intervention and data collection activities. Results may suggest what to modify to optimize the design and conduct, and ensure the integrity, of future multisite trials. Conducting process evaluations alongside clinical trials has the potential to improve our understanding of trial participant experiences. Results will provide a better understanding of how trial participants manage to engage in necessary trial activities along with other priorities.

scholarly journals Predicting disease course in ulcerative colitis using stool proteins identified through an aptamer-based screen

2021 ◽  
Vol 12 (1) ◽  
Author(s):  
Sanam Soomro ◽  
Suresh Venkateswaran ◽  
Kamala Vanarsa ◽  
Marwa Kharboutli ◽  
Malavika Nidhi ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Fecal Calprotectin ◽  
Disease Monitoring ◽  
Disease Course ◽  
Lipocalin 2 ◽  
Time Points ◽  
Inflammatory Bowel ◽  
Stool Samples

AbstractIn the search for improved stool biomarkers for inflammatory bowel disease (IBD), an aptamer-based screen of 1129 stool proteins was conducted using stool samples from an IBD cohort. Here we report that of the 20 proteins subsequently validated by ELISA, stool Ferritin, Fibrinogen, Haptoglobin, Hemoglobin, Lipocalin-2, MMP-12, MMP-9, Myeloperoxidase, PGRP-S, Properdin, Resistin, Serpin A4, and TIMP-1 are significantly elevated in both ulcerative colitis (UC) and Crohn’s disease (CD) compared to controls. When tested in a longitudinal cohort of 50 UC patients at 4 time-points, fecal Fibrinogen, MMP-8, PGRP-S, and TIMP-2 show the strongest positive correlation with concurrent PUCAI and PGA scores and are superior to fecal calprotectin. Unlike fecal calprotectin, baseline stool Fibrinogen, MMP-12, PGRP-S, TIMP-1, and TIMP-2 can predict clinical remission at Week-4. Here we show that stool proteins identified using the comprehensive aptamer-based screen are superior to fecal calprotectin alone in disease monitoring and prediction in IBD.

Adherence in inflammatory bowel disease (IBD): a clinical review

2019 ◽  
Vol 17 (6) ◽  
pp. 24-27
Author(s):  
Palle Bager ◽  
Susanna Jäghult
Keyword(s):  
Inflammatory Bowel Disease ◽  
Maintenance Therapy ◽  
Clinical Review ◽  
Bowel Disease ◽  
Topical Treatment ◽  
Disease Relapse ◽  
Adherence To Treatment ◽  
Different Types ◽  
Inflammatory Bowel ◽  
Stool Samples

Adherence to treatment can be challenging, especially in chronic diseases. In inflammatory bowel disease (IBD), maintenance therapy is common to prevent a disease relapse, and adherence becomes even more of a challenge during remission. Furthermore, practical problems with taking topical treatment can increase the likelihood of non-adherence. In IBD, the definition adherence can be expanded beyond taking medication to factors like leaving blood or stool samples, keeping appointments or adjusting behaviour regarding smoking or diet. This review provides a taxonomy of different types of non-adherence and indicates how these types call for different interventions. Furthermore, the article describes how IBD nurses can open up conversations with patients that will hopefully lead to improvements in their adherence.

scholarly journals Fifteen-Year-Old Male with Type 2 Autoimmune Pancreatitis: An Argument for Endoscopy

2017 ◽  
Vol 11 (2) ◽  
pp. 329-334
Author(s):  
Nathan T. Kolasinski ◽  
Marc T. Johannsen ◽  
Justin R. Hollon
Keyword(s):  
Inflammatory Bowel Disease ◽  
Autoimmune Pancreatitis ◽  
Bowel Disease ◽  
Serum Immunoglobulin ◽  
Immunoglobulin G4 ◽  
Early Therapy ◽  
Study Results ◽  
Inflammatory Bowel ◽  
Glutamyl Transferase

Type 2 autoimmune pancreatitis, an increasingly recognized etiology of pancreatitis in patients less than 20 years old, has characteristically been diagnosed with the histological finding of duct-centric pancreatitis in a patient who lacks elevated serum immunoglobulin G4. We present the case of a nonobese 15-year-old male, without any chronic medical conditions, who presented with the chief complaint of abdominal pain. The laboratory study results were remarkable for a lipase level of 5,419 U/L and a γ-glutamyl transferase level of 373 U/L. Magnetic resonance cholangiopancreatography revealed delayed contrast enhancement of the pancreas, diffuse parenchymal enlargement, and lack of normal lobulation. The patient’s serum immunoglobulin G4 level was found to be 66 mg/dL, which was within normal limits and supportive of a diagnosis of type 2 autoimmune pancreatitis. Despite the absence of intestinal complaints, the patient underwent subsequent endoscopy due to the correlation of type 2 autoimmune pancreatitis with inflammatory bowel disease that has been described in recent literature. Pan-colonic mild colitis was visualized, and the patient began treatment with steroids, to which he quickly responded. Performing endoscopy on this patient allowed for confident initiation of early therapy for both autoimmune pancreatitis and inflammatory bowel disease, and may have limited further surgical intervention and disease progression. For these reasons, this case highlights the utility of endoscopy in pediatric patients with suspected type 2 autoimmune pancreatitis, even in the absence of intestinal symptoms.

Su1223 Measurement of Inflammatory Bowel Disease Symptoms: Reliability of an Abbreviated Approach to Data Collection

2015 ◽  
Vol 148 (4) ◽  
pp. S-443
Author(s):  
Maria Paula Henao ◽  
Meenakshi Bewtra ◽  
Mark T. Osterman ◽  
Faten Aberra ◽  
Frank I. Scott ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Data Collection ◽  
Bowel Disease ◽  
Disease Symptoms ◽  
Inflammatory Bowel

scholarly journals Impact of biologics and small molecules for Inflammatory Bowel Disease on COVID-19 Related Hospitalization: A Systematic Review and Meta-analysis

2021 ◽  
Author(s):  
Fatema Alrashed ◽  
Hajer Alasfour ◽  
Mohammad Shehab
Keyword(s):  
Systematic Review ◽  
Inflammatory Bowel Disease ◽  
Relative Risk ◽  
Small Molecules ◽  
Bowel Disease ◽  
Biologic Therapy ◽  
Meta Analysis ◽  
Biological Therapies ◽  
Study Results ◽  
Inflammatory Bowel

Background The use of biological therapies and small molecules have been a concern for patients with inflammatory bowel disease (IBD) during COVID-19 pandemic. We aim to assess the association between risk of COVID-19 related hospitalization and these agents. Method A systematic review and meta-analysis of all published studies from December 2019 to September 2021 was performed to identify studies that reported COVID-19 related hospitalization in IBD patients receiving biological therapies or tofacitinib. The risk ratio (RR) was calculated to compare the relative risk of COVID-19 related hospitalization in patients receiving these medications to those who were not, at the time of the study. Results 18 studies were included. The relative risk of hospitalization was significantly lower in patients with IBD and COVID-19 who were receiving biologic therapy with RR of 0.47 (95% CI: 0.42-0.52, p < 0.00001). The RR was lower in patients receiving anti-TNFs compared to those who did not [RR= 0.48 (95% CI: 0.41-0.55, p < 0.00001)]. Similar finding was observed in patients taking ustekinumab [RR= 0.55 (95% CI: 0.43-0.72, p < 0.00001)]. Combination therapy of anti-TNF and an immunomodulator did not lower the risk of COVID-19 related hospitalization [RR= 0.98 (95% CI: 0.82-1.18, p =0.84]. The use of vedolizumab [RR= 1.13 (95% CI: 0.75-1.73, p =0.56] and tofacitinib [RR= 0.81 (95% CI: 0.49-1.33, p =0.40] was not associated with lower risk of COVID-19 related hospitalization. Conclusion Regarding COVID-19 related hospitalization in IBD, anti-TNFs and ustekinumab were associated with favorable outcomes. In addition, vedolizumab and tofacitinib were not associated with COVID-19 related hospitalization.

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